Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Double-blind, Vehicle-controlled, Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This randomized controlled trial aims to evaluate whether adjunctive tirofiban therapy combined with endovascular treatment (EVT) improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. Patients will be randomized to receive either tirofiban or matching placebo after EVT. The primary efficacy endpoint is the proportion of patients achieving functional independence (modified Rankin Scale 0-2) at 90±7 days, while the safety endpoint is the probability of symptomatic intracranial hemorrhagewithin 48 hours after randomization.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Pre-stroke modified Rankin Scale (mRS) score of 0-1

• Acute ischemic stroke symptoms present within 24 hours of last known well time

• Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6

• Anterior circulation: Alberta Stroke Program Early CT Score (ASPECTS) ≥6 Posterior circulation: pc-ASPECTS ≥6

• Occlusion of intracranial internal carotid artery (ICA), M1 segment of middle cerebral artery (MCA), V4 segment of vertebral artery, or basilar artery

• Clinical care team plans to perform endovascular thrombectomy (EVT)

• Subject or legally authorized representative can provide informed consent

• Residual stenosis ≥50% without planned angioplasty/stenting

Locations
Other Locations
China
Beijing Anzhen Hospital Affiliated to Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Xiaochuan Huo, Doctor
hxc810909@163.com
+86 13716292262
Backup
Xin Tong, Doctor
tomice123@foxmail.com
+86 17810651085
Time Frame
Start Date: 2025-08-15
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 716
Treatments
Experimental: Tirofiban group
Receive Tirofiban treatment following endovascular therapy
Placebo_comparator: placebo group
Receive placebo treatment after endovascular therapy.
Related Therapeutic Areas
Sponsors
Leads: Beijing Anzhen Hospital

This content was sourced from clinicaltrials.gov

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